buspirone for early satiety and symptoms of gastroparesis

Conditions: Gastroparesis

Summary: this study evaluates whether the study medication, buspirone, an antianxiety drug, improves the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately severe symptoms of fullness and/or inability to eat a full meal. half the patients will receive buspirone and half the patients will receive a placebo.

this is a multi-center, randomized, double-masked, placebo-controlled, parallel treatment groups phase 2 trial to determine the effect of buspirone, a 5-hydroxytryptamine (5-ht) 1a receptor agonist, on early satiety and postprandial fullness in participants with symptoms of gastroparesis and with at least moderately severe symptoms of early satiety and/or postprandial fullness. after enrollment, participants aged 18-75 years will be treated with buspirone (10 mg three times per day) or a matching placebo for 4 weeks, followed by a 2-week post-treatment washout period. the primary outcome for the study is 4-week change (week 4 minus baseline) in the 4-item postprandial fullness/early satiety subscore (higher scores indicate worse symptoms) from the patient assessment of gastrointestinal disorders symptom severity index (pagi-sym) gastroparesis cardinal symptom index (gcsi). we hypothesize that buspirone treatment will improve symptoms of postprandial fullness/early satiety compared to treatment with placebo, as indicated by a lower (smaller, more negative) 4-week change in the postprandial fullness/early satiety subscore in the buspirone arm compared to the placebo arm; change for a participant will be calculated as subscore at 4-weeks minus subscore at baseline.

Eligibility criteria:
inclusion criteria: * age 18 to 85 years of age at initial screening interview * symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview * diagnosis of either diabetic or idiopathic gastroparesis * delayed or normal gastric emptying retention on screening 4-hour gastric emptying scintigraphy test * symptoms of gastroparesis measured by the 9-item pagi-sym gastroparesis cardinal symptom index (gcsi) total score \> 2.0 at enrollment * symptomatic with postprandial fullness/early satiety severity at enrollment using the pagi-sym gcsi post-prandial fullness/early satiety subscore ≥ 3 * upper endoscopy or upper gi series without ulcers or mass lesions in the 2 years prior to enrollment exclusion criteria: * post-surgical gastroparesis, including prior pyloromyotomy, pyloric resection, vagotomy, bariatric surgery or post-nissen fundoplication * another active disorder which could explain symptoms in the opinion of the investigator * concurrent use of opiate narcotic analgesics more than 3 days per week * significant hepatic injury as defined by alanine aminotransferase (alt) elevation of greater than twice the upper limit of normal (uln) or a child-pugh score of 10 or greater * significant renal impairment as defined by serum creatinine \> 3.0 * uncontrolled diabetes defined as hba1c (%) of 10% or more within 60 days of enrollment * allergy to buspirone * concurrent or prior use (within 30 days) of monoamine oxidase (mao) inhibitors * concurrent or prior use (within 30 days) of benzodiazepines * concurrent or prior use (within 30 days) of buspirone, warfarin, haloperidol, and drugs to treat seizures (e.g., phenytoin and carbamazepine) * women breast feeding or known to be pregnant * any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study * failure to give informed consent

Keywords: gastroparesis early satiety stomach buspirone 5-ht 1a receptor agonist